成年癌症患者及其睡眠伴侣护理者失眠干预的简短行为治疗方案

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications Pub Date : 2025-04-19 DOI:10.1016/j.conctc.2025.101486

Youngmee Kim , Thomas C. Tsai , Wendy M. Troxel

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引用次数: 0

摘要

背景：睡眠障碍在癌症患者和他们的睡眠伴侣照顾者中都是常见的问题。虽然一个人的睡眠会影响伴侣的睡眠，但现有的心理行为干预措施都是针对患者和护理人员的睡眠问题独立进行的。方法将失眠简短行为治疗（BBTI）应用于癌症背景下的成年患者及其睡眠伴侣护理者。本方案旨在检验BBTI for Couples with Cancer （BBTI- cc）干预的可行性和可接受性，并提供初步疗效，以减少成人癌症患者及其睡眠伴侣照顾者的睡眠障碍，提高睡眠质量。干预将每周进行一次，持续4周。在基线（T1）和干预结束后一周（T2）收集问卷和每日睡眠记录。每周一次评估干预的满意度，持续4周。结果我们估计将纳入18对（18名患者和18名护理人员）。我们预计75%的符合条件和筛选的夫妇将在登记期内登记，80%的登记夫妇将完成干预，80%的参与者将报告所有可接受性措施的满意度。我们还预计BBTI-CC将显示出对睡眠效率（主要结果）、整体睡眠障碍、主观睡眠质量和失眠严重程度（次要结果）的中小型影响。结论本研究结果将为开展二元睡眠行为干预的可行性和可接受性提供依据，并为指导成年癌症患者及其睡眠伴护理者进一步完善干预内容和程序提供初步疗效数据。

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Protocol of Brief Behavioral Treatment for insomnia intervention for adult patients with cancer and their sleep-partner caregivers

Background

Sleep disturbance is common and problematic among both patients with cancer and their sleep-partner caregivers. Although one's sleep affects the partner's sleep, existing psychobehavioral interventions have targeted patients' and caregivers' sleep problems independently.

Methods

We adapt the Brief Behavioral Treatment for Insomnia (BBTI) for both adult patients and their sleep-partner caregivers in the context of cancer. This protocol is to test the feasibility and acceptability as well as to provide preliminary efficacy of the BBTI for Couples with Cancer (BBTI-CC) intervention, which is to reduce sleep disturbance and improving sleep quality of both adults with cancer and their sleep-partner caregivers. The intervention will be delivered weekly for 4 weeks. Questionnaire and daily sleep logs will be collected at baseline (T1) and one-week after conclusion of the intervention (T2). Satisfaction with the intervention will be assessed weekly for 4 weeks.

Results

We estimate 18 dyads will be enrolled (18 patients and 18 caregivers). We expect >75 % of eligible and screened dyads will enroll within the enrollment period, >80 % of enrolled dyads will complete the intervention, and >80 % of participants will report satisfaction across all acceptability measures. We also expect BBTI-CC will reveal a small-to-medium effect on sleep efficiency (primary outcome), overall sleep disturbance, subjective sleep quality, and insomnia severity (secondary outcomes).

Conclusions

Results will inform the feasibility and acceptability of conducting a dyadic sleep behavioral intervention, and provide preliminary efficacy data to guide further refinement of intervention content and procedure for adult patients with cancer and their sleep-partner caregivers.

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来源期刊

Contemporary Clinical Trials Communications Pharmacology, Toxicology and Pharmaceutics-Pharmacology

CiteScore

2.70

自引率

6.70%

发文量

146

审稿时长

20 weeks

期刊介绍： Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.